The Fountain Group

Currently I have an opening for a Quality Control Analyst (Biochemistry) located in Lexington, MA.. In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with general supervision.. Product Testing: Area focuses on techniques such as SDS-PAGE Silver, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmo, A280 etc., to support in-process, release, and stability testing.. Experience with BioChem Techniques such as: SDS-Page (Silver a plus), qPCR, Potency Assay, Kinetics Assay, Enzyme Activity, pH, Osmo, A280. Experience with Electronic Programs such as: Microsoft Office Suite, LIMS, LIS, SAP, Trackwise, etc.

quality control analyst

Currently I have an opening for aQuality Control Analyst (Biochemistry) located in Lexington, MA. Details for the position are as follows: Job Description:<ul> <li>Primary Duties of this position: will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. </li> <li>Testing may include but is not limited to samples from drug substance and drug product manufacturing, stability, and various protocol studies using approved test methods or test methods derived from QC technical protocols. May assist in sampling activities. The role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation. The introduction of new equipment and technology to improve sustainability and compliance is expected.</li> <li>This position is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business-appropriate quantities. </li> <li>In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with general supervision.</li> <li>Works under general supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.</li> <li>Product Testing: Area focuses on techniques such as SDS-PAGE Silver, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmo, A280 etc., to support in-process, release, and stability testing.</li> <li>Receives assignments in the form of objectives and establishes goals to meet objectives. Work is reviewed and measured based on meeting objectives and schedules. Establishes and recommends changes to policies that affect subordinate organizations.</li> <li>40-50%: Testing execution, participating in training analysts, troubleshooting methods</li> <li>20-30%: QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab housekeeping, and support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)</li> <li>10-20%: Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support</li> <li>Shift Schedule: Monday - Friday, 40hrs./week (100% Onsite)</li> <li>Pay Rate: $45 - 58/Hour</li></ul>Qualifications:<ul> <li>Bachelor Degree with 5+ Years</li> <li>Experience in Quality Control (QC Testing, Stability Analysis, etc.)</li> <li>Experience within a GMP/cGMP Environment </li> <li>Experience with BioChem Techniques such as: SDS-Page (Silver a plus), qPCR, Potency Assay, Kinetics Assay, Enzyme Activity, pH, Osmo, A280</li> <li>Experience with Electronic Programs such as: Microsoft Office Suite, LIMS, LIS, SAP, Trackwise, etc. </li> <li>Contract to Start, conversion/extension on performance</li></ul> Who We Are: The Fountain Group is a nationwide staffing firm with over 80 Fortune 100-500 clients. Since 2001, TFG has maintained a consistent standard of excellence, and our work is broadly recognized every year through numerous industry performance awards. Our success is a team effort. Browse our website below for additional information on our company. The Fountain Group "We work in Life Sciences, Clinical, Engineering, IT, and more. Above all, we specialize in people."

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